A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: placebo; Drug: pramlintide acetate

• Registration Number: NCT00189514
• Lead Sponsor: AstraZeneca

Brief Summary

This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Subject has completed Protocol 137OB-201.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	placebo	-
1	pramlintide acetate	-
2	pramlintide acetate	-
3	pramlintide acetate	-

Primary Outcome Measures

Name	Time	Method
Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.	open ended
Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.	open ended

Secondary Outcome Measures

Name	Time	Method
Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters.	open ended

Trial Locations

Locations (1)

Research Site; 🇺🇸 Olympia, Washington, United States